BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT

    K Number: K954700 · Decision Dec 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    49
    Applicant Total
    15
    Review Days
    64

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
    K Number
    K954700
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Helix Diagnostics, Inc.
    Date Received
    October 12, 1995
    Decision Date
    December 15, 1995
    Product Code
    LKJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LKJ Antinuclear Antibody, Antigen, Control

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LKJ), ordered by most recent decision date.

    EliA Ro52, EliA Ro60

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANA-SCREEN WITH MDSS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    AESKULISA ANA HEP-2, REF 30-7115US

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200

    FDA 510(k)
    FDA Class 2 ·Immunology

    ATHENA MULTI-LYTE ANA-II TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Helix Diagnostics, Inc.

    K Number Device Name
    K001900 ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
    K000489 ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
    K980337 DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
    K960091 ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
    K954723 ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
    K952253 ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
    K951850 ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
    K951798 ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT
    K940510 ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
    K940588 ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT
    Search all 15 clearances from Helix Diagnostics, Inc. →